Aurora 2 Series recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: AUR7-LH/7TV-LH; Serial Numbers: 09010002, 9020003, 9020004, 9020007, 9020008, 9020009, 9020010, 9020011, 9020012, 9020013, 9020014, 9020015, 9020016, 9030017, 9030018, 9030019, 9030020, 9030021, 9030022, 9040023, 9040024, 9040025, 9040026, 9040027, 9040028, 9040029, 9040030, 9040031, 9040032, 9040033, 9040034, 9040035, 9040036, 9040037, 9040038, 9040039, 9040040, 9040041, 9040042, 9050043, 9050044, 9050045, 9050046, 9050047, 9050048, 9050049, 9050050, 9050051, 9050052, 9050053, 9050054, 9050055, 9050056, 9050057, 9050058, 9050059, 9050060, 9050061, 9050062, 9050063, 9050064, 9050065, 9050066, 9050067, 9050068, 9050069, 9050070, 9050071, 9050072, 9060073, 9060074, 9060075, 9060076, 9060077, 9060078, 9060079, 9060080, 9060081, 9060082, 9060083, 9060084, 9060085, 9060086, 9060087, 9060088, 9060089, 9060090, 9060091, 9060092, 9080093, 9080094, 9080095, 9080097, 9080098, 9080099, 9080100, 9080101, 9080102, 9080104, 9080105, 9080106, 9080107, 9090108, 9090109, 9090110, 9090111, 9090112, 9090113, 9090114, 9090115, 9090116, 9090117, 9090118, 9090119, 9110120, 9110121, 9110122, 9110123, 9110124, 9110125, 9110126, 9110127, 9110128, 9110129, 9110130, 9120131, 9120132, 9120133, 9120134, 9120135, 9120136, 9120137, 9120138, 9120139, 9120140, 9120141, 09120142, 9120143, 9120144, 10010145, 10010146, 10010147, 10010148, 10010149, 10010150, 10010151, 10010152, 10010153, 10010154, 10010155, 10010156, 10010157, 10010158, 10020159, 10020160, 10020161, 10020162, 10020163, 10020164, 10020165, 10020166, 10030167, 10030168, 10030169, 10030170, 10030171, 10030172, 10030173, 10030174, 10030175, 10040176, 10040177, 10040178, 10040179, 10040180, 10040181, 10040182, 10040183, 10040184, 10040185, 10040186, 10040187, 10040188, 10040189, 10040190, 10040191, 10040192, 10040193, 10040194, 10040195, 10040196, 10040197, 10040198, 10040199, 10040200, 10040201, 10040202, 10040203, 10040204, 10040205, 10050206, 10050207, 10050208, 10050209, 10050210, 10050211, 10050212, 10050213, 10050214, 10050215, 10050216, 10050217, 10050218, 10050219, 10050220, 10050221, 10050222, 10050223, 10050224, 10050225, 10050226, 10050227, 10050228, 10050229, 10050230, 10050231, 10050232, 10050233, 10050234, 10050235, 10050236, 10050237, 10050238, 10050239, 10050240, 10050241, 10050242, 10060243, 10060244, 10060245, 10060246, 10060247, 10060248, 10060249, 10060250, 10060251, 10060252, 10060253, 10060254, 10060255, 10070256, 10070257, 10070258, 10070259, 10070260, 10070261, 10070262, 10070263, 10070264, 10080265, 10080266, 10080267, 10080268, 10080269, 10080270, 10080271, 10080272, 10080273, 10080274, 10080275, 10080276, 10080277, 10080290, 10090278, 10090279, 10090280, 10090281, 10090282, 10090283, 10090284, 10090285, 10090286, 10090287, 10090288, 10090289, 10090291, 10100292, 10100293, 10100294, 10100295, 10110296, 10110297, 10110298, 10110299, 10110300, 10110301, 10110302, 11010303, 11010304, 11010305, 11010306, 11010307, 11010308, 11010309, 11010310, 11010311, 11010312, 11010313, 11010314, 11010315, 11010316, 11010317, 11010318, 11010319, 11010320, 11020321, 11020322, 11020323, 11020324, 11020325, 11020326, 11020327, 11020328, 11020329, 11020330, 11020331, 11020332, 11020333, 11020334, 11020335, 11030336, 11030337, 11030338, 11030339, 11030340, 11030341, 11030342, 11030343, 11030344, 11030345, 11030346, 11030347, 11030348, 11030349, 11030350, 11030351, 11030352, 11030353, 11040354, 11040355, 11040356, 11040357, 11040358, 11040359, 11040360, 11040361, 11040362, 11040363, 11040364, 11040365, 11040366, 11040367, 11040368, 11040369, 11040370, 11040371, 11040372, 11040373, 11050374, 11050375, 11050376, 11050377, 11050378, 11060379, 11060380, 11060381, 11060382, 11060383, 11060384, 11060385, 11060386, 11060387, 11060388, 11060389, 11060390, 11060391, 11060392, 11060393, 11060394, 11060395, 11060396, 11060397, 11060398, 11060399, 11060400, 11060401, 11060402, 11060403, 11060404, 11060405, 11060406, 11060407, 11060408, 11060409, 11060410, 11060411, 11060412, 11070413, 11070414, 11070415, 11070416, 11070417, 11070418, 11070419, 11070420, 11070421, 11070422, 11080423, 11080424, 11080425, 11080426, 11080427, 11080428, 11080429, 11080430, 11080431, 11080432, 11080433, 11080434, 11090435, 11090436, 11090437, 11090438, 11090439, 11090440, 11090441, 11090442, 11090443, 11090444, 11090445, 11090446, 11090447, 11090448, 11090449, 11090450, 11090451, 11090452, 11090453, 11090454, 11090455, 11100456, 11100457, 11100458, 11100459, 11100460, 11100461, 11110463, 11110464, 11110465, 11110466, 11110467, 11110468, 11110469, 11110470, 11110471, 11110472, 11110473, 11110474, 11110475, 11110476, 11110477, 11110478, 11110479, 11110480, 11110481, 11110482, 11110483, 11110484, 11110485, 11110486, 11110487, 11110488, 11110489, 11120490, 11120491, 11120492, 11120493, 11120494, 11120495, 11120496, 11120497, 11120498, 11120499, 11120500, 11120501, 11120502, 11120503, 11120504, 12010505, 12010506, 12010507, 12010508, 12010509, 12010510, 12010511, 12010512, 12010513, 12010514, 12020515, 12020516, 12020517, 12020518, 12020519, 12020520, 12020521, 12020522, 12020523, 12020524, 12020525, 12020526, 12020527, 12020528, 12020529, 12040530, 12040531, 12040532, 12040533, 12040534, 12040535, 12040536, 12040537, 12040538, 12040539, 12040540, 12040541, 12040542, 12040543, 12040544, 12040545, 12040546, 12040547, 12040548, 12040549, 12040550, 12040551, 12040552, 12040553, 12040554, 12040556, 12040557, 12040558, 12040559, 12050560, 12050561, 12050562, 12050563, 12050564, 12050565, 12050566, 12050567, 12050568, 12050569, 12050570, 12050571, 12050572, 12060573, 12060574, 12060575, 12060576, 12060577, 12060578, 12060579, 12060580, 12060581, 12060582, 12060583, 12060584, 12060585, 12060586, 12060587, 12070588, 12070589, 12070590, 12070591, 12070592, 12070593, 12070594, 12070595, 12070596, 12070597, 12070598, 12080599, 12080600, 12080601, 12080602, 12080603, 12080604, 12080605, 12080606, 12080607, 12080608, 12080609, 12080610, 12080611, 12080612, 12080613, 12080614, 12080615, 12080616, 12080617, 12080618, 12080619, 12080620, 12080621, 12080622, 12080623, 12080624, 12080625, 12080626, 12080627, 12080628, 12080629, 12080630, 12080631, 12090632, 12090633, 12090634, 12090635, 12090636, 12090637, 12090638, 12090639, 12090640, 12090641, 12090642, 12090643, 12100644, 12100645, 12100646, 12100647, 12100648, 12100649, 12100650, 12100651, 12100652, 12100653, 12100654, 12100655, 12100832, 12110656, 12110657, 12110658, 12110659, 12110660, 12110661, 12110662, 12110663, 12110664, 12110665, 12110666, 12110667, 12110668, 12110669, 12110670, 12110671, 12110672, 12110673, 12110674, 12110675, 12110676, 12110677, 12110678, 12110679, 12110680, 12110681, 12110682, 12110683, 12110684, 12110685, 12120686, 12120687, 12120688, 12120689, 12120690, 12120691, 12120692, 12120693, 12120694, 12120695, 12120696, 12120697, 13010698, 13010699, 13010700, 13010701, 13010702, 13010703, 13010704, 13010705, 13010706, 13010707, 13010708, 13010709, 13010710, 13010711, 13010712, 13020713, 13020714, 13020715, 13020716, 13020717, 13020718, 13020719, 13020720, 13020721, 13020722, 13020723, 13020724, 13020725, 13020726, 13020727, 13020728, 13020729, 13020730, 13020731, 13020732, 13030735, 13030736, 13030737, 13030738, 13030739, 13030740, 13030741, 13030742, 13030743, 13030744, 13030745, 13030746, 13030747, 13030748, 13030749, 13030750, 13030751, 13030752, 13030753, 13060754, 13060755, 13060756, 13060757, 13060758, 13060759, 13060760, 13060761, 13060762, 13060763, 13060764, 13060765, 13060766, 13060767, 13060768, 13060769, 13060770, 13070771, 13070772, 13070773, 13070774, 13070775, 13070776, 13070777, 13070778, 13070779, 13070780, 13070781, 13070782, 13070783, 13070784, 13070785, 13070786, 13070787, 13080788, 13080789, 13080790, 13080791, 13080792, 13080793, 13080794, 13080795, 13080796, 13080797, 13100798, 13100799, 13100800, 13100801, 13100802, 13100803, 13100804, 13100805, 13100806, 13100807, 13100808, 13100809, 13100810, 13100811, 13100812, 13100813, 13100814, 13100815, 13100816, 13100817, 13100818, 13100819, 13100820, 13100821, 13100822, 13100823, 13100824, 13100825, 13100826, 13100827, 13100828, 20040831, 08120001 (PROTO),

Product

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure…

Recalling firm

DKK Dai-Ichi Shomei Co., Ltd.

Quantity

822 units

Distribution

Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.

Recall date

August 21, 2024

Classification

Class II

Status

Ongoing

Agency

FDA (device)